Mineral Tinted SPF 30

Product NDC: 49358-571
11-digit product format: 493580571
Labeler code: 49358
Product ID: 49358-571_36d86ec1-c63c-d417-e063-6394a90a5f9f
Type: HUMAN OTC DRUG
Nonproprietary name: Titanium Dioxide and Zinc Oxide
Dosage form: CREAM
Route: TOPICAL
Labeler: MDSolarSciences
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-07-01
Substance: TITANIUM DIOXIDE; ZINC OXIDE
Active strength: 20; 170 mg/mL; mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49358-571-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49358-571-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49358-571-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49358-571-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49358-571-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49358-571-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49358-571-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Mineral Tinted SPF 30
Brand name suffix: Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TITANIUM DIOXIDE	20 mg/mL
ZINC OXIDE	170 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
15FIX9V2JP	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
adcd6881-fa25-4312-95e5-5b47102aa6b9	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49358-571-01	2025-06-05	C162847	48780-1	2cef2736-6b69-d83d-e063-dadaa90ab31f	Mineral Tinted Crème SPF 30 Mineral Tinted Crème SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)
49358-571-01	2025-01-30	C162847	48780-1	2cef2736-6b69-d83d-e063-dadaa90ab31f	Mineral Tinted Crème SPF 30 Mineral Tinted Crème SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49358-571-01	Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	1 in 1 CARTON	CREAM	1		2
49358-571-01	Mineral Tinted SPF 30Mineral Tinted SPF 30 Broad Spectrum Sunscreen Water Resistant (80 min)	50 mL in 1 TUBE	CREAM	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49358-571	MINERAL TINTED SPF 30 MINERAL TINTED SPF 30 BROAD SPECTRUM SUNSCREEN WATER RESISTANT (80 MIN) (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [MDSOLARSCIENCES]	1	Current NDC, 2 package rows	20230910_adcd6881-fa25-4312-95e5-5b47102aa6b9.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 88 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Drs. pharmacy sunscreen SPF 50 (physical filters)	SUNSCREEN SPF 50	OL PHARMA TECH LLC. (Drs. Pharmacy)	315a5ca4-4536-d585-e063-6294a90a1c50	2026-01-06	Warnings	Exact identifier application number: M020
Drs. pharmacy sunscreen SPF 30 (Physical Filters)	SUNSCREEN SPF 30	OL PHARMA TECH LLC. (Drs. Pharmacy)	315a5b1f-9dc2-a243-e063-6394a90a5e08	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	51f759b7-8c49-41d4-aaa3-f901d599cac5	2026-01-06	Warnings	Exact identifier application number: M020
cle de peau BEAUTE SYNACTIF DAYTIME MOISTURIZER ENRICHED n (Refill)	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	463dc557-9743-4a38-969e-2c78fc10ee2a	2026-01-06	Warnings	Exact identifier application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING n	AVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONE	SHISEIDO AMERICAS CORPORATION	23bb4225-bfb5-47e2-80fe-733761ba4069	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO WHITE LUCENT DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	e881e637-e0f0-4c90-8343-2be6e74020b8	2026-01-06	Warnings	Exact identifier application number: M020
Hawaiian Tropic Lip Balm Sunscreen SPF 30	AVOBENZONE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	c7b71be3-f906-bd09-e053-2995a90adc61	2026-01-06	Warnings	Exact identifier application number: M020
SHISEIDO BENEFIANCE WRINKLERESIST24 DAY	AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE	SHISEIDO AMERICAS CORPORATION	d308d578-c881-4c10-8c79-9e3cd58b694c	2026-01-06	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen Lip Balm SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,	Beiersdorf Inc	47bc6776-1130-0162-e063-6294a90a2adc	2026-01-06	Warnings	Exact identifier application number: M020
HAWAIIAN TROPIC	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	088fa3cd-b9b8-d10b-e063-6394a90a7fd6	2026-01-06	Warnings	Exact identifier application number: M020
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil	HOMOSALATE, OCTISALATE, OCTOCRYLENE	Naples Soap Company, Inc.	47c147a9-c4f4-ab82-e063-6394a90aaa5c	2026-01-06	Warnings	Exact identifier application number: M020
PoutScreen Lip Treatment Love Letter	AVOBENZONE, OCTINOXATE, OCTOCRYLENE	NAKED SUNDAYS PTY LTD	47d22c6d-49fd-f97c-e063-6294a90a6ba1	2026-01-06	Warnings	Exact identifier application number: M020
Moisturizing Antioxidant SPF 50	OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDE	Topiderm, Inc.	727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f	2026-01-05	Warnings	Exact identifier application number: M020
EVERYRAY SUNCARE SUNSHINE SERUM	EVERYRAY SUNCARE SUNSHINE SERUM	Guangzhou Fantesy Biotechnology Co.,Ltd	062be336-2af4-10e2-e063-6294a90a480a	2026-01-05	Warnings	Exact identifier application number: M020
sunscreen powder	SUNSCREEN POWDER	Guangzhou Fantesy Biotechnology Co.,Ltd	fae8ecaf-7a9c-902b-e053-6394a90a5f31	2026-01-05	Warnings	Exact identifier application number: M020
ORLASKIN HYDRATING SUNSCREEN	ORLASKIN HYDRATING SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	0808b0cd-2cfb-8554-e063-6294a90ad6c4	2026-01-05	Warnings	Exact identifier application number: M020
DALLAS JAMES SKINCARE CO. SPF 50 Sunscreen	DALLAS JAMES SKINCARE CO. SPF 50 SUNSCREEN	Guangzhou Fantesy Biotechnology Co.,Ltd	225faeec-4f96-e082-e063-6394a90a9a31	2026-01-05	Warnings	Exact identifier application number: M020
LING NEW YORK Save Face Broad Spectrum SPF 30	LING NEW YORK SAVE FACE BROAD SPECTRUM SPF 30	Guangzhou Fantesy Biotechnology Co.,Ltd	1dfa80bd-495a-18fb-e063-6394a90a4d0d	2026-01-05	Warnings	Exact identifier application number: M020
Sky and Sol Sunscreen SPF30	SKY AND SOL SUNSCREEN SPF30	Guangzhou Fantesy Biotechnology Co.,Ltd	1d917329-dea2-e792-e063-6294a90a0a0d	2026-01-05	Warnings	Exact identifier application number: M020
Sky and Sol Sunscreen SPF50	SKY AND SOL SUNSCREEN SPF50	Guangzhou Fantesy Biotechnology Co.,Ltd	1c699b06-c156-b0da-e063-6294a90a947d	2026-01-05	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
49358-571-01	49358057101	1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE	1 tube	2023-07-01	No	No	Current